NCT04342780

Brief Summary

This study evaluates the prevalence of delayed chemotherapy induced nausea in adult oncology patients in real clinical practice of day clinics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 29, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

March 25, 2020

Last Update Submit

April 17, 2024

Conditions

Keywords

prevalencechemotherapy-induced nausea and vomitingoncologysuportive care

Outcome Measures

Primary Outcomes (1)

  • delayed Nausea

    nausea that occurs 24 hours to 5 days after chemotherapy (100mm VAS in diary)

    Each patient: each days for 5 days after chemotherapy; recruitment: six weeks

Secondary Outcomes (6)

  • acute nausea

    Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks

  • acute and delayed vomiting

    Each patient: each day for 5 days after chemotherapy; recruitment: six weeks

  • adherence to antiemetics

    Each patient: each day for 5 days after chemotherapy; recruitment: six weeks

  • antiemetic prescription

    Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks

  • interference of nausea or vomiting with everyday life

    Each patient: measured at day 5 after chemotherapy; recruitment: six weeks

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult oncology patients in dayclinics

You may qualify if:

  • first day of chemotherapy of a new cycle (any cycle)
  • speak and write German
  • sign the consent forms

You may not qualify if:

  • cognitive or linguistic impairments that would significantly impede consent or participation (as assessed by the nurses in charge)
  • accompanying radiotherapy;
  • pre-existing nausea within three days before the start of the first chemotherapy in this cycle; and
  • prior participation in CINrate (each person participates only once)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZeTuP

Sankt Gallen, 9000, Switzerland

Location

Related Publications (1)

  • Engst R, Glaus A, Moessner U, Ott S, Koller A. Delayed Chemotherapy-Induced Nausea - A Nurse-Led International Observational Study in Routine Oncology Practice (CINrate). SAGE Open Nurs. 2025 Dec 2;11:23779608251398116. doi: 10.1177/23779608251398116. eCollection 2025 Jan-Dec.

MeSH Terms

Conditions

VomitingNeoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antje Koller

    Ostschweizer Fachhochschule St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2020

First Posted

April 13, 2020

Study Start

June 29, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations